Evaluation of the Effect of Laser Acupuncture on Taxane Acute Pain Syndrome Patients

Joint Pain Clinical Trial

Official title:

Evaluation of the Effect of Laser Acupuncture on Myalgia and Arthralgia During Docetaxel or Paclitaxel Treatment in Cancer Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04872556
• Other study ID #: 202001710A3
• Status: Terminated
• Phase: N/A
• Start date: May 13, 2021
• Est. completion date: February 24, 2022

Study information

• Verified date: March 2021
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospectively randomized and double-blinded clinical study. Cancer patients were suffered from the taxanes-induced joint pain, and would be advised to receive laser acupuncture in specific points to relieve pain. Clinical effects of analgesic changes would be evaluated before and after the intervention. The inflammation associated indices would be further analyzed to reveal the therapeutic mechanism of laser acupuncture. The laser acupuncture was expected to relief taxanes-induced adverse effects in patients and also can improve patients' life quality.

Description:

The current clinical study is prospectively randomized and double-blinded, and practice in Chang Gung Memorial Hospital in Linkou, TaoYuan and Taipei branches. All 90 participants suffered from taxanes-induced myalgia and Arthralgia, and will be randomly assigned into the experimental groups (45 participants) and the control group (45 participants). The experiment group would arrange laser acupuncture on day1 and day3 after Taxanes treatment, besides the control group arrange pseudo-laser acupuncture. In the mean while, blood tests were performed with the C-Reactive protein, erythrocyte sedimentation rate, Interleukin-6 for each participants. Evaluation would be records on day1, day3, and day 8 after Taxanes treatment.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: February 24, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Cancer patients received taxanes treatment and complained with myalgia and Arthralgia in the first taxanes treatment course.

2. Age between 20-70 years old

3. The NRS (numerical rating scale) score of pain increased more than 2 after the treatment.

4. Both 1st and 2nd taxanes treatment with the same dose

Exclusion Criteria:

1. Receiving acupuncture or herbal medicine over past three months

2. Myalgia and arthralgia were not due to taxanes treatment such osteoarthritis or rheumatic arthritis

3. Wounds or skin infections over laser acupuncture points

4. Refuse assign information consent or follow study protocol

Related Conditions & MeSH terms

• Arthralgia
• Joint Pain
• Pain Cancer

Intervention

Device:
• Laser acupuncture device
The experiment group would arrange laser acupuncture on day1 and day3 after Taxanes treatment. In the mean while, blood tests were performed with the C-Reactive protein, erythrocyte sedimentation rate, Interleukin-6 for each participants. Evaluation would be records on day1, day3, and day 8 after Taxanes treatment.
• Pseudo-laser acupuncture
The experiment group would arrange Pseudo-laser acupuncture on day1 and day3 after Taxanes treatment. In the mean while, blood tests were performed with the C-Reactive protein, erythrocyte sedimentation rate, Interleukin-6 for each participants. Evaluation would be records on day1, day3, and day 8 after Taxanes treatment.

Locations

Country	Name	City	State
Taiwan	ChangGung Memorial Hospital	TaoYuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NRS on Day 1	Numerical rating scale in pain evaluation	Day 1 after Taxanes treatment
Primary	NRS on Day 3	Numerical rating scale in pain evaluation	Day 3 after Taxanes treatment
Primary	NRS on Day 8	Numerical rating scale in pain evaluation	Day 8 after Taxanes treatment
Secondary	Inflammation assessment	Inflammation associated indices: C-Reactive protein	Day 1 and day 3
Secondary	Inflammation assessment	Inflammation associated indices: erythrocyte sedimentation rate	Day 1 and day 3
Secondary	Inflammation assessment	Inflammation associated indices: Interleukin-6	Day 1 and day 3
Secondary	Functional Assessment of Cancer Therapy-General Scale on Day 1	A Taxanes treatment questionnaire	Day 1
Secondary	Functional Assessment of Cancer Therapy-General Scale on Day 3	A Taxanes treatment questionnaire	Day 3
Secondary	Functional Assessment of Cancer Therapy-General Scale on Day 8	A Taxanes treatment questionnaire	Day 8